The ideal candidate will conduct method investigations, method validations, method transfers, and method comparisons. Initiates analytical development projects and assists in experimental design and critically analyzes

data in support of project directives.  Working experience in microbiological quality control, particularly in sterility assurance, bioburden analysis and processes where contamination control is critical skill.

Act as laboratory liaison to internal and external customers in support of analytical chemistry activities. Performs quality control testing and trains others in area(s) of expertise.

Responsibilities

·               Carry out responsibilities following the organization’s policies, procedures, and state, federal and local laws.

·               Prepare method development, method feasibility, method validation, analytical strategy reports, and other relevant scientific information packages for internal and external use by the Company.

·               Write, review, and execute protocols and reports for method investigation/method validation independently. Investigations may be complex and validations may require advanced technical and analytical problem-solving skills.

·               Performs method development projects working with senior colleagues for direction/consultation.

·               Perform and interpret sterility testing, bioburden evaluations, and bacterial endotoxin (LAL) assays according to compendial methods (e.g. USP <71>, <61>, <85>). Support contamination control investigations and assist in identifying root causes of microbial excursions.

·               Serve as the department representative for site projects/initiatives. Provide scientific and technical support to laboratory personnel.

·               Train personnel on analytical instrumentation, techniques, and projects.

·               Provide support for laboratory investigations, conduct validation studies, and assist in writing project plans and experimental designs.

·               Review and report on compendial and FDA guidelines revisions. Develop department strategy.

·               Design databases and spreadsheets; utilizes statistical and laboratory/data applications to solve analytical problems and display data/results.

·               Carrie out cGMP and technical training, as it pertains to area of work.

·               Perform advanced instrument troubleshooting.

·               Provide support and coaching to subordinate employees in the areas of training, planning, and work assignments.

·               May develop, write, and review new procedures, test methods, and specifications documents. May also update existing procedures, test methods, and specifications documents.

·               Ensure project deadlines and performance standards are established and met.

Required Knowledge, Skills, and Abilities

·               Current Good Manufacturing Practices (cGMP), Food and Drug Administration (FDA), ICH, ISO, and other regulatory requirements.

·               UV/IR, HPLC, and GC instruments, dissolution testing, operation methods, and techniques.

·               Advanced Chemistry, pharmaceutical, and statistical theories, methods, and procedures.

·               Hands on experience with sterility testing, bioburden testing, and endotoxin testing

·               Business, scientific, and personal computer hardware and software applications.

·               Business English usage, spelling, grammar, and punctuation.

·               Supervision, leadership, and training practices and methods.

·               Working with a high degree of independence and of conceiving and achieving technical goals with little or no technical supervision. Training of junior staff.

·               Managing multiple projects, duties, and assignments.

·               Coordinating and reviewing the work of assigned department personnel.

·               Technical report writing.

·               Establishing and maintaining cooperative working relationships with others.

·               Ensuring compliance with all Company policies and procedures, including safety rules and regulations.

Required Education and Experience

• Bachelor’s Degree in Chemistry or related science field
• 7+ years of related experience in the pharmaceutical industry; or an equivalent combination of education and experience.
• Knowledge of FDA, cGLP, cGMP, and SOP regulatory rules, regulations and guidelines.
• Prior involvement in method development or validation of microbiological assays is a plus.